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Inability of Generic Drug Manufacturers to Warn of Newly Discovered Hazards Puts Patients at Risk; Serious Safety Hazards Often Take Years to Emerge

New Public Citizen Report Highlights Need to Allow Generic Drug Manufacturers to Update Labeling as They Learn of New Risks

WASHINGTON, D.C. – Many potential hazards are not discovered until years after drugs have been on the market, a Public Citizen report released today finds, yet generic drug manufacturers can do little to warn doctors and patients about newly discovered information, putting patients at risk.

Safety issues often arise years after the generic version of a drug has entered the market – sometimes more than a decade later. At least 53 drugs approved by the Food and Drug Administration (FDA) more than 10 years ago have required new black-box warnings over the past five years, the new Public Citizen report shows.

Over the past 30 years, sales of generic drugs have skyrocketed, and generics now constitute the majority of all prescriptions filled. Despite considerable changes in the market, FDA regulation of generic labeling has remained substantially unchanged.

Generic manufacturers are not permitted to update product labeling to reflect newly discovered information about safety risks unless they are mimicking a change already made by the brand-name manufacturer or ordered by the FDA to revise the labeling. Yet Public Citizen’s report lists 434 generic drugs for which no brand-name product remains on the market.

Regulatory revisions are needed to bring post-market regulation in line with the realities of the pharmaceutical market and to help ensure that drug labeling provides adequate warnings to patients based on information that comes to light after the drug is approved for marketing.

“Generic drug manufacturers’ inability under current regulations to update the labeling of their products poses a threat to the safety of prescription drugs, creating unnecessary risks to patients,” stated Dr. Michael Carome, director of Public Citizen’s Health Research Group.

To assess the scope of the safety gap, Public Citizen looked at significant labeling changes made after a generic drug came on the market during a five-year period. The organization found 53 drugs for which the FDA required a new black-box warning – the most serious type of warning, calling attention to serious or life-threatening risks – after a generic entered the market. Of the 53, 11 are currently marketed only as generics, while 38 are still marketed in both brand-name and generic versions. One is sold only as a brand-name drug, and three are no longer sold at all.

With many drugs, the dangers take years – sometimes decades – to emerge. Reglan, for instance, was approved in various forms between 1979 and 1983 to treat gastrointestinal issues. It received its first black-box warning in 2009 – more than 30 years later – after doctors discovered it could cause tardive dyskinesia, a serious, irreversible movement disorder. When the FDA announced the warning, more than 2 million people were taking products containing the drug.

Similarly, Darvon was first approved for pain relief in 1957 and Darvocet in 1972. The FDA called for an additional black-box warning in 2009 due to the risk of overdose when used with other pain medications. At the FDA’s request, manufacturers took the drugs off the market in 2010 – 53 years after Darvon first came onto the market – citing the potential to cause serious heart damage.

Currently, FDA rules prohibit generic manufacturers from updating product labeling even if they become aware of a potential risk not stated in the labeling. In contrast, the FDA allows brand-name drug manufacturers to update warnings and precautions on product labeling before getting FDA approval. The generic drugmaker is required to match its labeling to brand-name labeling. Last year, 80 percent of prescriptions filled in the U.S. were filled with generics.

In August 2011, Public Citizen submitted a citizen petition to the FDA to request that the agency amend its regulations to allow generic drug manufacturers to take advantage of the same procedures for updating labeling that are currently available to brand-name manufacturers. The FDA has not responded substantively to the petition.

Allowing generic drug manufacturers to provide updated safety information would have two beneficial effects. First, in light of the large market share of generic drugs, it would help to ensure that drug labeling provides adequate warnings to patients based on information that comes to light after the drug is approved for marketing.

Second, because the U.S. Supreme Court held in PLIVA, Inc. v. Mensing in 2011 that a patient harmed by a generic drug that had inadequate labeling cannot sue the manufacturer for compensation for her injuries, revised regulations would correct the illogical disparity between the rights of patients injured by generic drugs and the rights of those injured by brand-name drugs.

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